Search results for " microbial"
Article
Being Thorough When Transferring Technology
This is particularly true for microbial fermentations. In the case of microbial fermentation, heating and mass transfer demands can often be controlled by the fed-batch feed rate. Thus, you want to us…
Article
Selecting a Comprehensive Bioburden Reduction Plan
If components or equipment are different for processes, such as microbial fermentation and mammalian culture, a separate risk analysis is performed for each process.
Personnel Training
BioPhar…
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Risk Assessment and Mitigation in Biopharmaceutical Manufacturing
…uring compared with solid-dosage manufacturing?
AstraZeneca: In biopharmaceutical manufacturing, microbial contamination is usually the greatest overall risk. The primary factors that affect the …
Article
What’s New in Upstream Technologies
Integrated online biomass measurement
Sartorius Stedim Biotech (SSB) added an integrated online biomass measurement to its ambr 15 fermentation and ambr 250 high throughput systems for microbial a…
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Ensuring Viral Safety of Viral Vaccines and Vectors
The master cell bank (MCB), the starting material for the entire production process, requires a one-time, full characterization of microbial and viral contaminants. The working cell bank (WCB) require…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
Fujifilm develops and manufactures biologics using both microbial and mammalian production systems, and although single-use technology is a relatively new introduction, it has had an impact on mammali…
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Trends in Single-use Bioreactors
In addition, there are new systems now specifically designed for microbial fermentation.
Ang (Eppendorf): Most notable is the innovation of single-use bioreactors suitable for microbial fermenta…
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Stirring up the fermentation game
XDR-50 MO fermentor vessel and I/O cabinet
Introduction
The adoption of single-use technology by biomanufacturers using microbial systems has been inhibited by the lack of single-use …
Article
A Look Ahead at BioPharma Manufacturing and Regulation
MICROBIAL CONTAMINATION
BioPharm: Priority 3 of the August 2011 strategic plan calls for reducing microbial contamination of medical products. What specific goals does FDA have in this area?
…
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Best Practices for Selecting a Top-Quality Cell Line
…erted in the right location in the genome with the right dosage, and that the cell line is free from microbial contamination,” he explains.
As a result, a high-quality CAR-T-cell line should n…